Excerpts from decision below:
“As with any relevant medical record, the signed consent form and treatment note are to be weighed by the Board, along with any other evidence in the record relevant to the issue.7
Savage v. Shinseki, 24 Vet.App. 259, 272 (2011) (noting that private medical record had to be weighed against other evidence in record); Roberts, supra.
=========================================
“Nonetheless, this does not relieve the Board of its duty to make credibility determinations and otherwise weigh all of the evidence submitted, including lay evidence, and to adequately explain the reasons or bases for its assignment of weight and ultimate determinations. See Jandreau v. Nicholson, 492 F.3d 1372, 1376 (Fed. Cir. 2007) (Board has duty to weigh and determine credibility of all evidence, and explain its findings in statement of reasons or bases).
Here, the Board essentially found that the preponderance of the evidence
was against Ms. McNair’s assertion that she was not informed that she might suffer from neuralgia as a result of the surgery, but the Board’s statement of reasons or bases in support of its determination is inadequate.
Its only stated basis for this finding is the bald statement that “based
upon the evidence in this case a reasonable person could assume that the surgeon’s detailed discussion addressing possible residual scarring includes associated neuralgic pain.” No rationale is provided for concluding what a
reasonable person could assume, frustrating judicial review. Allday v.
Brown, 7 Vet.App. 517, 527 (1995) (holding that the Board’s statement “must be adequate to enable a claimant to understand the precise basis for the Board’s decision, as well as to facilitate review in this Court”).
—————————————————-
UNITED STATES COURT OF APPEALS FOR VETERANS CLAIMS
NO. 09-1813
ANDREA M. MCNAIR, APPELLANT,
V.
ERIC K. SHINSEKI,
SECRETARY OF VETERANS AFFAIRS, APPELLEE.
On Appeal from the Board of Veterans’ Appeals
(Argued May 25, 2011
Decided November 18, 2011)
Ronald L. Smith, with whom Virginia L. Carron and Troy E. Grabow were on
the brief, all
of Washington, D.C., for the appellant.
Kristen D. King-Holland, with whom Will A. Gunn, General Counsel; R.
Randall Campbell,
Assistant General Counsel; and Carolyn F. Washington, Deputy Assistant
General Counsel, were
on the brief, all of Washington, D.C., for the appellee.
Before KASOLD, Chief Judge, and HAGEL and MOORMAN, Judges.
KASOLD, Chief Judge: Veteran Andrea M. McNair appeals through counsel that
part of a
January 22, 2009, decision of the Board of Veterans’ Appeals (Board) that
denied disability
compensation for neuralgia1
of the breast or focal nerve damage (hereinafter “neuralgia”) as a result
of surgery she underwent at a VA facility in June 1998. On appeal, Ms.
McNair argues, inter alia,
that the Board erred when it found that she was advised adequately of the
potential adverse effects
of her surgeryand therefore that her consent to the surgerywas informed.
Ms. McNair seeksreversal
of the Board’s decision. The Secretary disputes Ms. McNair’s contentions.
The case was referred to a panel of the Court to address the evidentiary
effect of a signed
generic consent form when the patient signing the form asserts that she
was not informed of a
foreseeable risk of surgery. For the reasons stated below, we hold that
the presumption of regularity
does not apply to the scope of the information provided to a patient by a
doctor with regard to the
“Neuralgia” is pain extending along the course of one or more nerves.
DORLAND’S ILLUSTRATED MEDICAL
DICTIONARY 1281 (31st ed. 2007) [hereinafter “DORLAND’S”].
1
risks involved with any particular treatment. We further hold that a
failure to provide information
to a patient about a potential adverse effect does not defeat a finding of
informed consent if a
reasonable person faced with similar circumstances would have proceeded
with the treatment.
Becauseadditionalfindings offact arenecessaryto applytheseholdings,
theBoard’sdecision
will be set aside and the matters remanded for further adjudication.
I. FACTS
Ms. McNair served on active duty in the U.S. Army from August 1993 to May
1995. Prior
to her service – in August 1989 – Ms. McNair underwent breast
reduction surgery. She did not
report any complications as a result of that procedure. On June 2, 1998,
she underwent bilateral
reduction mammoplasty at a VA hospital.2
Ms. McNair and her doctor signed an authorization for
medical procedures form that reflects that she was advised as to the
nature of the surgery, attendant
risks involved, and expected results, but the form is general in nature
and does not state the specific
attendant risks that were discussed. Record (R.) at 448. In addition, a
contemporaneously entered
treatment notestatesthatthis wasMs.McNair’s secondbreast-reduction surgery,
whichwasrequired
after Ms. McNair developed macromastia3
subsequent to her original surgery, with symptoms
including neck, back, and shoulder pain, significant “bra strapping,” and
decreased physical activity
due to the size and positions of the breasts. R. at 442. Another treatment
note detailed the surgeon’s
conversation with Ms. McNair regarding the risks and tradeoffs of the
surgery:
The nature of the operation including the tradeoff b/t scar or [illegible]
of excess
skin, adipose and glandular tissue were discussed in great detail
including the
potential complications of infection, hematoma, partial or complete NAC
[nipple-areolar complex] graft loss as well as irregular pigmentation
during the
healing [illegible]. The pt acknowledged the above and instruct[ed] to
proceed.
R. at 452.
In November 1998, Ms. McNair filed a claim under 38 U.S.C. § 1151 for
continual neuralgia
resulting from breast reduction surgery. In a March 1999 rating decision,
a VA regional office found
A “mammoplasty” (or “mammaplasty”) reduction is the plastic reconstruction
of the breast to reduce size.
DORLAND’S at 1116.
3
2
“Macromastia” is oversize of the breasts. DORLAND’S at 1108.
2
that Ms. McNair was not entitled to such benefits because “[b]oth the
private and VA examiner
indicate that such pain from nerveregeneration after the elective
surgeryis an expected consequence
of such surgery.” R. at 435. Ms. McNair appealed that decision, stating
that she did not experience
pain after her first surgeryand reiterating that she was not informed of
the chance of this type of pain
occurring. Since then, this matter has been the subject of several Board
decisions, a joint motion for
remand granted bythis Court, and numerous VA medical examinations. Ms.
McNair has contended
throughout this time that she was not informed of the risk of neuralgia
prior to her June 1998
surgery.
In the decision on appeal, the Board found that Ms. McNair suffers from an
additional
disability due to neuralgia that was incurred as a result of the June 1998
surgery. The Board further
found that neuralgia was a foreseeable risk of surgery but that Ms. McNair
was not entitled to
disability compensation because (1) there was no evidence of negligence or
similar instance of fault
on the part of VA in furnishing surgical treatment, and (2) Ms. McNair
provided informed consent
for treatment. Regarding the informed consent finding, the Board found
that there was substantial
compliance with 38 C.F.R. § 17.32, the regulation governing the provision
and documentation of
consent to medical procedures such as surgery. The Board further found
that (1) there is no VA
regulatory requirement that every foreseeable risk be documented in the
record, (2) to the extent the
record does not document that neuralgic scar pain was a possible risk,
this omission was a minor
deviation from the requirements of § 17.32 that was immaterial under the
circumstances of this case,
and (3) “in this case a reasonable person could assume that the surgeon’s
detailed discussion
addressing possible residual scarring includes associated neuralgic pain.”
R. at 13. This appeal
followed.
II. ARGUMENTS
Ms. McNair argues that none of the evidence in the record establishes that
the specific risk
of neuralgia was disclosed to her and that the only affirmative evidence
of record on that point
consists of her lay statements that she was not so informed – statements
that she asserts were not
weighed by the Board. She further argues that there is no support for the
Board’s finding that any
failure to document neuralgia in the record was a minor and immaterial
deviation under 38 C.F.R.
3
§3.361(d)(1)(ii). When questionedatoralargument,Ms. McNair
clarifiedherposition, andasserted
that the regulation’s reference to “minor” and “immaterial” deviations
includes only minor mistakes
in documenting the consent, such as ascribing the wrong date to an
otherwise properly executed
consent form. She also argued that this case is distinguishable from
Halcomb v. Shinseki, 23
Vet.App.234(2009),becauseinthatcasetheveterandid notprovide anysupporting
evidence,”even
[considering] his own laystatements,” whereas here Ms. McNair
consistentlyhas stated that she was
not advised that she might suffer from neuralgia as a result of her
surgery.
The Secretary argues that the Board’s findings of fact are not clearly
erroneous because Ms.
McNair signed a consent form in which she attested that she understood the
nature of the proposed
procedure, attendant risks involved, and the expected results. Because the
form is congruent with
VA regulatory and internal procedures, the Secretary cites to our decision
in Halcomb and argues
that it cannot be presumed that the risk of neuralgia was not discussed
simply because it was not
specifically recorded. As to Ms. McNair’s contrary lay statements, the
Secretary argues that the
Board sufficiently addressed them when the Board found that the health
care providers substantially
complied with 38 C.F.R. § 17.32 and also that minor deviations from the
requirements of § 17.32
that are immaterial will not defeat a finding of informed consent. In
response to questioning at oral
argument,theSecretaryassertedthatminor andimmaterialdeviationsunder§3.361(
d)(1)(ii)include
a failure to disclose a risk that, had it been known to a reasonable
person in Ms. McNair’s
circumstances, would not havedeterredareasonableperson from undergoing
surgery. Additionally,
in response to questioning, the Secretary argued that the presumption of
regularity applied to the
facts of this case and Ms. McNair’s statements alone were insufficient to
rebut it.
III. DISCUSSION
The law authorizes VA compensation for disabilities arising from, inter
alia, negligently
provided VA medical or surgical treatment. 38 U.S.C. § 1151. The
implementing VA regulation
provides that negligence is established when the VA-provided treatment is
the proximate cause of
a disability and, inter alia, the treatment was provided without informed
consent. 38 C.F.R.
4
§ 3.361(c)(1),(d)(1)(ii) (2011);4
see also Halcomb, 23 Vet.App.at 237-38 (explaining the regulatory
framework in detail). To be informed, consent must be given freely after
careful explanation of the
course of the treatment to be provided, including, inter alia, the
reasonably foreseeable risks
associated with the treatment.5
38 C.F.R. §§ 17.32(c) (2011),6
3.361(c)(1), (d)(1)(ii) (referring to
4
38 C.F.R. § 3.361 states:
(c) Establishing the cause of additional disability or death. Claims based
on additional disability or death due
to hospital care, medical or surgical treatment, or examination must meet
the causation requirements of this
paragraph and paragraph (d)(1) . . . of this section . . . .
(1) Actual causation required. To establish causation, the evidence must
show that the hospital care,
medical or surgical treatment, or examination resulted in the veteran’s
additional disability or death.
Merely showing that a veteran received care, treatment, or examination and
that the veteran has an
additional disability or died does not establish cause.
….
(d) Establishing the proximate cause of additional disability or death.
The proximate cause of disability or
death is the action or event that directly caused the disability or death,
as distinguished from a remote
contributing cause.
(1) Care, treatment or examination. To establish that carelessness,
negligence, lack of proper skill,
error in judgment, or similar instance of fault on VA’s part in furnishing
hospital care, medical or
surgicaltreatment,or
examinationproximatelycausedaveteran’sadditionaldisabilityor death, itmust
be shown that the hospital care, medical or surgical treatment, or
examination caused the veteran’s
additional disability or death (as explained in paragraph (c) of this
section); and
(i) VA failed to exercise the degree of care that would be expected of a
reasonable health
care provider; or
(ii) VA furnished the hospital care, medical or surgical treatment, or
examination without the
veteran’s or, in appropriate cases, the veteran’s representative’s
informed consent. To
determine whether there was informed consent, VA will consider whether the
health care
providers substantially complied with the requirements of § 17.32 of this
chapter. Minor
deviations from the requirement of § 17.32 of this chapter that are
immaterial under the
circumstances of a case will not defeat a finding of informed consent.
Consent may be
express (i.e., given orally or in writing) or implied under the
circumstances specified in
§ 17.32(b) of this chapter, as in emergency situations.
The VA regulation is consistent with the generally accepted rule that a
physician must provide the patient with
enough information to enable the patient’s informed choice whether to
undergo treatment, Canterbury v. Spence,
464 F.2d 772, 786 (D.C. Cir. 1972) (adopting the patient-perspective duty),
which, in turn, is premised on the principle
that a person “has a right to determine what shall be done with his own
body,” Schloendorff v. Soc’y of N.Y. Hosp.,
105 N.E. 92 (N.Y. 1914) (Cardozo, J.).
6
5
38 C.F.R. § 17.32(c) states:
General requirements for informed consent. Informed consent is the freely
given consent that follows a careful
explanation by the practitioner to the patient or the patient’s surrogate
of the proposed diagnostic or therapeutic
5
§ 17.32).
Additionally, 38 C.F.R. § 17.32(d) provides that “[t]he informed consent
process must be
appropriately documented in the health record.” The Secretary determined
that a signed, generic
consent form satisfies this documentation requirement, and this
determination was upheld in
Halcomb, supra. Specifically left unaddressed in Halcomb, however, is the
evidentiary effect of
such a generic consent form when the scope of the advice provided to a
patient-turned-claimant is
contested by the claimant. 23 Vet.App. at 239-41 (rejecting the argument
that use of the generic
consent form established negligence per se because it did not list the
foreseeable risks attendant with
the treatment, and noting that the appellant had not presented any
evidence – not even his own
statement – that consent was not informed).
A. Presumption of Regularity
There is a presumption that public officers perform their official duties
correctly, fairly, in
good faith, and in accordance with law and governing regulations. Marsh v.
Nicholson, 19 Vet.App.
381, 385 (2005); see also Rizzo v. Shinseki, 580 F.3d 1288, 1292 (Fed. Cir.
2009) (applying the
presumption of regularityto the competence of VA examiners).
Thepresumption applies with equal
force whether its application favors the Government or the individual
seeking disability
compensation from the Government. Woods v. Gober, 14 Vet.App. 214, 218 (
2000); cf. United
States v. Chem. Found. Inc., 272 U.S. 1 (1926) (rejecting the Government’s
claim that sales of
intellectual property were induced fraudulently because United States
officers were presumed to be
aware of the facts when the transactions were made absent clear evidence
to the contrary). Whether
the presumption of regularity attaches to the public actions of a public
official is a question of law
that the Court reviews de novo. Marsh, 19 Vet.App. at 386.
Although Ms. McNair contended at oral argument that the presumption of
regularity applies
only to ministerial acts, the presumption is not so limited. Rizzo, 580 F.
3d at 1292 (noting that
procedure or course of treatment. The practitioner, who has primary
responsibility for the patient or who will
perform the particular procedure or provide the treatment, must explain in
language understandable to the
patient or surrogate the nature of a proposed procedure or treatment; the
expected benefits; reasonably
foreseeableassociated risks,complicationsor sideeffects;
reasonableandavailablealternatives;andanticipated
results if nothing is done. The patient or surrogate must be given the
opportunity to ask questions, to indicate
comprehension of the information provided, and to grant permission freely
without coercion. The practitioner
must advise the patient or surrogate if the proposed treatment is novel or
unorthodox. The patient or surrogate
may withhold or revoke his or her consent at any time.
6
“nothing in this court’s precedent limits the presumption [of regularity]
to procedural matters” and
further stating that the doctrine “‘allows courts to presume that what
appears regular is regular, the
burden shifting to the attacker to show the contrary'” (quoting Butler v.
Principi, 244 F.3d 1337,
1340 (Fed Cir. 2001))); see also Sickels v. Shinseki, 643 F.3d 1362 (Fed.
Cir. 2011) (applying
presumption of regularityto medical examiners’ overall competence,
including abilityto understand
instructions); Rios v. Nicholson, 490 F.3d 928, 930-31 (Fed. Cir. 2007) (
applying presumption to the
“known course of business” of the U.S. Postal Service).
Even though Ms. McNair’s contention that the presumption of regularity
only applies to
ministerial acts is not the law, we do not agree with the Secretary that
the presumption broadly
applies to the scope of the advice and information given by a doctor to
his patient. The issue before
the Court is not resolved simply because the Board may presume the
competence of VA medical
professionals in general, or their ability to understand instructions, as
were the circumstances,
respectively, in Rizzo and Sickles, both supra. A VA doctor is a public
official and completion of
an informed consent form is required by VA regulation before certain
treatment may be provided to
a patient. However, it is the content of the advice and information
provided to the patient in the face
of a signed generic consent form that is contested here. As a matter of
logic, such advice and
information, which is predicated on the unique characteristics of each
patient and each medical
procedure, is not the “the product of a consistent, reliable procedure,”
which is the “root” of the
presumption of regularity in our caselaw. Posey v. Shinseki, 23 Vet.App.
406, 410 (2010). It is
precisely the diversity of patients, procedures, and circumstances that
counsels against recognizing a presumption that a doctor has fully informed a particular patient about a particular consequence of a particular medical procedure simply because a generic consent form has been filled out properly.
When there is a dispute concerning what information a doctor provided to
his patient, a factual issue is raised whether a generic consent form indicating the patient was advised of the risks of surgery is more probative than the claimant’s statements that a specific risk of the surgery was not discussed. See Salis v. United States, 522 F. Supp. 989, 1000 (M.D. Pa. 1981) (noting that when there is a general consent form and contrary lay assertions, the issue becomes one of credibility for the trier of fact). Because such a finding has its basis in fact, it is a determination to be made by the Board in the first instance, based on all of the evidence in the record. Roberts v. Shinseki,
7
23 Vet.App. 416, 423 (2010) (Board has duty to weigh and analyze all the
evidence of record (citing Burger v. Brown, 5 Vet.App. 340, 342 (1993))).
Here, contrary to Ms. McNair’s contention, her statements are not the only
evidence on the issue of informed consent. As with any relevant medical record, the signed consent form and treatment note are to be weighed by the Board, along with any other evidence in the record relevant to the issue.7
Savage v. Shinseki, 24 Vet.App. 259, 272 (2011) (noting that private medical record had to be weighed against other evidence in record); Roberts, supra.
Moreover, to the extent Ms. McNair contends that witness testimony necessarily carries greater weight than documents, she is mistaken. E.g., United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1948) (giving little weight to testimony in conflict with contemporaneous documents). Nonetheless, this does not relieve the Board of its duty to make credibility determinations and otherwise weigh all of the evidence submitted, including lay evidence, and to adequately explain the reasons or bases for its assignment of weight and ultimate determinations. See Jandreau v. Nicholson, 492 F.3d 1372, 1376 (Fed. Cir. 2007) (Board has duty to weigh and determine credibility of all evidence,
and explain its findings in statement of reasons or bases).
Here, the Board essentially found that the preponderance of the evidence
was against Ms. McNair’s assertion that she was not informed that she might suffer from neuralgia as a result of the surgery, but the Board’s statement of reasons or bases in support of its determination is inadequate.
Its only stated basis for this finding is the bald statement that “based
upon the evidence in this case a reasonable person could assume that the surgeon’s detailed discussion addressing possible residual scarring includes associated neuralgic pain.” No rationale is provided for concluding what a
reasonable person could assume, frustrating judicial review. Allday v.
Brown, 7 Vet.App. 517, 527 (1995) (holding that the Board’s statement “must be adequate to enable a claimant to understand the precise basis for the Board’s decision, as well as to facilitate review in this Court”).
Although remand generally is warranted because our review of the Board’s
findings is
frustrated, see Tucker v. West, 11 Vet.App. 369, 374 (1998) (remand is
appropriate “wherethe Board
has incorrectly applied the law, failed to provide an adequate statement
of reasons or bases for its
By referencing the consent form and the treatment note, we do not imply
that there is no other evidence in
the record pertaining to this issue.
7
8
determinations, or where the record is otherwise inadequate”), in this
instance we must also address
whether the failure to provide notice that neuralgia was a risk associated
with surgery can constitute
a minor deviation that does not defeat a finding that consent was informed.
This is required because
if such failure can be deemed minor, and if the Board properly found that
it was, Ms. McNair’s basis
for claiming that her consent was not informed would fail, and remand
would not be warranted.
38 U.S.C. § 7261(b)(2) (Court must consider rule of prejudicial error);
Conway v. Principi, 353 F.3d
1369, 1374 (Fed. Cir. 2004) (same); cf. Valiao v. Principi, 17 Vet.App.
229, 232 (2003) (under the prejudicial error rule, remand is unnecessary “where the facts averred by a claimant cannot conceivably result in any disposition of the appeal other than affirmance of the Board decision”).
B. Minor Deviations Immaterial Under the Circumstances of a Case
The Board decision on appeal states that any failure to document neuralgia
was a minor deviation that was immaterial under the circumstances of this case.
However, the Board failed to provide a rationale for this determination or explain why not mentioning neuralgia would constitute such a minor deviation. In response to questioning at oral argument, the Secretary stated that he
viewed 38 C.F.R. § 3.361(d)(1)(ii) to mean the failure to advise a
patient about a reasonably
foreseeable consequence of treatment is a minor, nonmaterial deviation if
a reasonable person under
the circumstances would have consented to the treatment anyway.
When the Secretary offers an interpretation of his own regulation for the
first time in
litigation, that interpretation generally is entitled to deference “‘as
long as there is no reason to
suspectthattheinterpretation doesnot reflecttheagency’s
fairandconsideredjudgment.'” Singleton v. Shinseki, 23 Vet.App. 376, 379 (2010) (quoting Cathedral Candle Co. v. U.S. Int’l Trade Comm’n, 400 F.3d 1352, 1364 (Fed. Cir. 2005)) (internal quotation marks omitted); see also Bowen v. Georgetown Univ. Hosp., 488 U.S. 204 (1988) (“Deference to what appears to be nothing more than an agency’s convenient litigating position would be entirely inappropriate.”); Reizensteinv.Shinseki, 583 F.3d 1331 (Fed. Cir. 2009) (noting that, generally, an “agency’s construction of its own regulations is of controlling weight unless it is plainly erroneous or inconsistent with the regulation”). Here, a fair reading of the regulation and the Secretary’s
stated understanding of the regulation when promulgated, 69 Fed. Reg. 46,426, 46,429 (Aug. 3, 2004) (“[
T]he provisions of
9
§ 3.361(d)(1) are intended merely to restate, more simply and clearly,
the [common law] standards
governing determinations of negligence.”), support the Secretary’s
interpretation presented during
oral argument and, for the reasons stated below, we find this
interpretation to be a reasonable
application of the statute. 38 U.S.C. § 7261(a)(1) (questions of law are
reviewed de novo); Lane v.
Principi, 339 F.3d 1331, 1339 (Fed. Cir. 2003) (“[I]nterpretation of a
statute or regulation is a
question of law . . . .”); see also Kamen v. Kemper Fin. Servs., Inc., 500
U.S. 90, 99 (1991) (“When
an issue or claim is properly before the court, the court is not limited
to the particular legal theories
advanced by the parties, but rather retains the independent power to
identify and apply the proper
construction of governing law.”); Forshey v. Principi, 284 F.3d 1335, 1356 (
Fed. Cir. 2002) (“[W]e
may decide to apply the correct law even if the parties do not argue it,
if an issue is properly before
this court.”).
The text of § 3.361(d)(1)(ii) and its placement in the overall regulatory
scheme demonstrate
that the term “minor deviations” includes substantive as well as technical
or procedural errors. See
Buczynski v. Shinseki, 24 Vet.App. 221, 227 (2009) (noting that
regulatory interpretation focuses on
the regulatory text as well as the overall structure of the
regulatory provisions). The regulation states
that a finding of informed consent will not be defeated bya minor
deviation that is “immaterial under
the circumstances of a case.” 38 C.F.R. § 3.361(d)(1)(ii). With regard to
substantial compliance and
minor deviations,§3.361(d)(1)(ii)referstwiceto §17.32asawhole,
whichcontains both procedural
and substantive requirements. Compare 38 C.F.R. § 17.32(d) (”
Documentation of informed
consent.”), with 38 C.F.R. § 17.32(c) (“General requirements for informed
consent.”). The cross
reference to both proceduralandsubstantiverequirementssupports
the conclusion that even a failure
to comply with a substantive requirement could, under some circumstances,
constitute a minor,
immaterial deviation. See Buczynski, supra (noting that specific limitations
of regulatory provisions generally are noted if intended).
This interpretation also is consistent with common law principles that
form the basis of
§ 3.361(d)(1), as stated by the Secretary when he promulgated this
regulation. See 69 Fed. Reg. at
46,429. Pertinent hereto, common law generally holds that “the test for
determining whether a
particular peril must be divulged is its materiality to the patient’s
decision.” Canterbury, 464 F.2d
10
at 791; see also Canesi v. Wilson, 730 A.2d 805, 812 (N.J. 1999);
Getchell v. Mansfield, 489 P.2d
953, 955-56 (Or. 1971).
The majority of jurisdictions also determine “materiality” based upon an
objective standard
that, at least in part, asks whether the potentially undisclosed risk is
of the type that if known by a
reasonable person under similar circumstances would cause that person not
to have undergone
treatment.8
See, e.g., Bernard v. Char, 903 P.2d 667 (Haw. 1995); Canterbury, 464 F.2d
at 786-87;
K.A.C. v. Benson, 527 N.W.2d 553, 561 (Minn. 1995); Schreiber v.
Physicians Ins. Co. of Wis.,
588 N.W.2d 26, 33 (Wis. 1999); Sherwood, 805 P.2d at 465 (“Applying the
objective test is fair to
the patient because it requires consideration by the factfinder of what a
reasonable person with all
of the characteristics of the plaintiff would have done under the same
circumstances . . . and is
likewise fair to the physician-defendant because the physician is not
placed in jeopardy of the
patient’s hindsight.”). To answer this question, the adjudicator not only
must look to the likelihood
of an undisclosed risk materializing, but also recognize that some
foreseeable risks may be minor
when compared to the foreseeable consequences of continuing without
undergoing the treatment.
See Smith v. Cotter, 810 P.2d 1204, 1209 (Nev. 1991) (determining that the
plaintiff’s thyroid
problem was a minor irritant when compared to the risk of permanent vocal
cord paralysis).
In sum, given the regulatory text and structure as well as the history of
the promulgation of
§ 3.361(d)(1)(ii) and the general common law understanding of informed
consent, we agree with the
Secretary’s interpretation that the failure to advise a patient of a
foreseeable risk can be considered
a minor, immaterial deviation under the regulation if a reasonable person
in similar circumstances
would have proceeded with the medical treatment even if informed of the
foreseeable risk. Of
course, such an assessment is a factual one for the Board to make in the
first instance. Roberts,
23 Vet.App. at 423.
The minority of jurisdictions use a subjective standard to determine
materiality, under which a patient must
show that she herself (as opposed to a reasonable person in her position)
would not have consented to the treatment had
she been adequately informed. Sherwood v. Carter, 805 P.2d 452, 465 (Idaho
1991). There is no reason to believe that
the Secretary intended to apply this position, see e.g., 69 Fed. Reg. at
46,429, and the Court declines to adopt it, given
the inherent difficulties it imposes on the finder-of-fact, as well as the
possibility that a patient who dies as a result of
a medical procedure will be foreclosed from any recovery because she
cannot testify as to what her subjective belief was
at the time of the procedure. See Fain v. Smith, 479 So.2d 1150 (Ala. 1985
) (noting the inherent difficulties).
8
11
Here, the Board provided no discussion as to whether a reasonable person
in Ms. McNair’s
situation would have proceeded with the surgery even if advised of the risk
that she could suffer from
neuralgia as a result of that surgery. Moreover, the Board did not discuss,
and the record does not
reflect, the consequences of proceeding with surgery versus foregoing
surgery, which are key factors
upon which one might evaluate whether a reasonable person would have
proceeded with the surgery.
In the absence of such determination and a properly developed record, or
other explanation
supporting the Board’s bald conclusion, judicial review of this issue is
frustrated. 38 U.S.C.
§ 7104(d)(1) (requiring a statement of reasons or bases in support of the
Board’s findings and
conclusions on all material issues presented on the record); Allday, supra.
C. Remand
Remand is warranted for the Board to address, in the first instance, and
to develop, as
needed,9
facts related to the scope of information provided to Ms. McNair regarding
the foreseeable risks of her treatment, the foreseeable consequences of failing to undergo treatment, and whether a reasonable person would have proceeded with the surgery even if advised of the risk of neuralgia pursuant to § 3.361(d)(1)(ii). Tucker, supra; Webster v. Derwinski, 1 Vet.App. 155, 159 (1991)
(Court is not to conduct de novo factfinding but rather to remand the case
for the Board to find facts in the first instance, subject to later review by Court). On remand, Ms. McNair may present, and the Board must consider, any additional evidence and argument in support of the matters remanded. See
Kay v. Principi, 16 Vet.App. 529, 534 (2002). These matters are to be
provided expeditious
treatment on remand. See 38 U.S.C. § 7112.
IV. CONCLUSION
Upon consideration of the foregoing, the Board’s January 22, 2009,
decision is SET ASIDE
and the matter REMANDED for adjudication consistent with this decision.
Of note, the record reflects that Ms. McNair’s representative requested
that the Secretary obtain further
information from the VA hospital regarding her informed consent but the
Board found that any such effort would be
futile because the evidence already was sufficient for an adequate
determination.
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